BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    MDR report key: 13321444 · Received January 21, 2022

    Report

    Report Number
    1025402-2022-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    January 5, 2022
    Report Date
    June 20, 2022
    Manufacturer
    LEE LABORATORIES, INC.
    Product Code
    MDB
    UDI-DI
    00382902451242
    PMA / PMN Number
    K974883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    MGIT 960 SUPPLEMENT KIT BATCH 1070802 IS COMPOSED OF MGIT PANTA BATCH 1070798 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1070799. THE BATCH HISTORY RECORD REVIEW FOR MGIT 960 SUPPLEMENT KIT BATCH 1070802 WAS SATISFACTORY. NO QUALITY NOTIFICATIONS WERE GENERATED DURING MANUFACTURING AND NO OTHER COMPLAINTS HAVE BEEN TAKEN ON THIS KIT BATCH. MGIT PANTA IS MANUFACTURED BY REHYDRATING COMPONENTS IN USP PURIFIED WATER AND MIXED INTO A HOMOGENOUS SOLUTION. THE SOLUTION IS THEN STERILE FILTERED, DISPENSED INTO VIALS AND STOPPERED BY MACHINE. THE VIALS ARE LYOPHILIZED, AND CRIMP CAPS ARE APPLIED PER STANDARD OPERATING PROCEDURES (SOP). MGIT 960 GROWTH SUPPLEMENT IS MANUFACTURED BY REHYDRATING THE MEDIA COMPONENTS WITH USP PURIFIED WATER AND MIXED UNTIL A HOMOGENEOUS SOLUTION IS OBTAINED. THE SOLUTION IS THEN STERILE FILTERED AND DISPENSED INTO VIALS; STOPPERS ARE MANUALLY PLACED IN THE VIAL OPENING; SEPTUM CAPS ARE MANUALLY PLACED ON TOP OF THE STOPPER AND THEN MECHANICALLY CRIMPED PER SOP. SIX MGIT PANTA VIALS ARE THEN MANUALLY PACKAGED WITH SIX MGIT GROWTH SUPPLEMENT VIALS TO MAKE A MGIT 960 SUPPLEMENT KIT (MATERIAL 245124). THE BATCH HISTORY RECORD REVIEWS FOR MGIT PANTA BATCH 1070798 AND MGIT 960 GROWTH SUPPLEMENT BATCH 1070799 WERE SATISFACTORY AND NO NOTIFICATIONS WERE GENERATED DURING MANUFACTURING. QC INSPECTION AND TESTING WERE SATISFACTORY AT TIME OF RELEASE. RETENTIONS FOR PANTA BATCH 1070798 (10 VIALS) AND GROWTH SUPPLEMENT BATCH 1070799 (VIALS) WERE AVAILABLE FOR INSPECTION. FOR PANTA BATCH 1070798 ALL 10/10 RETENTION VIALS HAD NO DEFECTS OR DAMAGE FROM VISUAL INSPECTION. FOR GROWTH SUPPLEMENT BATCH 1070799, ALL 4/4 RETENTION VIALS HAD NO DAMAGE. FOR INVESTIGATION OF THE COMPLAINT TWO PANTA RETENTION VIALS FROM BATCH 1070798 WERE RECONSTITUTED WITH TWO RETENTION GROWTH SUPPLEMENT VIALS FROM BATCH 1070799. ONE RECONSTITUTED PANTA VIAL AND GROWTH SUPPLEMENT VIAL WAS PLACED INTO 20¿25-DEGREE CELSIUS INCUBATOR. ONE RECONSTITUTED PANTA VIAL AND GROWTH SUPPLEMENT VIAL WAS PLACED INTO 33¿37-DEGREE CELSIUS INCUBATOR. AT THE END OF A SEVEN-DAY INCUBATION PERIOD THERE WAS NO MICROBIAL GROWTH OBSERVED IN ANY OF THE VIALS AT EITHER TEMPERATURE. TWO PHOTOS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION: THE FIRST PHOTO SHOWS A RECONSTITUTED PANTA VIAL WITH THE CRIMP CAP REMOVED FROM THE VIAL. THE MGIT PANTA LABEL CAN BE SEEN BUT NOT THE ACTUAL BATCH INFORMATION. THE SECOND PHOTO SHOWS A RECONSTITUTED UNCRIMPED AND CAPPED PANTA VIAL. THERE DOES APPEAR TO BE A DARK SUBSTANCE IN THE VIAL. THE BATCH INFORMATION CANNOT BE SEEN IN THE PHOTO PROVIDED. WITHOUT BATCH INFORMATION A PHOTO ALONE CANNOT CONFIRM A COMPLAINT. A PHOTO MUST PROVIDE THE DEFECT, AND CLEAR INDICATION OF THE PRODUCT INFORMATION SUCH AS MATERIAL, AND BATCH/LOT NUMBER. NO RETURNS WERE RECEIVED TO ASSIST WITH THE INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED. BD WILL CONTINUE TO TREND COMPLAINTS FOR CONTAMINATION. NOTES. RISK MANAGEMENT REVIEW INDICATES THE POTENTIAL RISK OF THE DEFECT REPORTED WAS ASSESSED AS SEVERITY S3, PER [BALTRMLMBACTECMGITAPH, REV 03, ID 4.0.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT EXPERIENCED BIOLOGICAL CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: MOLD CONTAMINATION IN THE BOTTLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT EXPERIENCED BIOLOGICAL CONTAMINATION. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT, AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: MOLD CONTAMINATION IN THE BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063331 BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT BLOOD CULTURE BROTH KIT MDB LEE LABORATORIES, INC. 245124 1070802 00382902451242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown